- ConvaTec (Lexington, MA)
- …form of technical presentations & reports. + Collaborate with project management, regulatory , clinical, etc. teams to stay aligned on key goals, deliverables, ... cross-functional teams + A strong and reliable safety mindset **Qualifications/Education:** PhD in biology, bioengineering, materials science, or a related field… more
- The MITRE Corporation (Bedford, MA)
- …and consulting to our Federal Government clients in transforming their technologic and regulatory processes to enhance the safety, stability, and security of the US ... Finance, Financial Market Microstructure and Regulation, Payment Systems, Fintech, Regulatory Tech and Supervisory Tech, Financial Analytics, Market Modeling and… more
- Pfizer (Cambridge, MA)
- …investigator brochures, clinical study reports, statistical analysis plan, and regulatory documents. + Provide leadership to early stage clinical scientists ... with other clinicians, statisticians, clinical pharmacologists, translational biologists and regulatory specialists. Meet regularly with the Pfizer Oncology group… more
- Sanofi Group (Cambridge, MA)
- …controlled timelines. The role also includes preparing reports suitable for regulatory submissions to support clinical development. The ideal candidate will have ... data interpretation, and ensuring compliance with internal best practices and regulatory guidance + Oversee and mentor junior analysts in method validation… more
- Sanofi Group (Cambridge, MA)
- …program strategy and the network of collaborators from research to operational, regulatory , and commercial functions. Success in this role requires the ability to ... The GPH will be delegated such responsibilities as interaction with regulatory /health authorities, approval of protocols, informed consent documents, clinical study… more
- ICON Clinical Research (Boston, MA)
- …statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents, as assigned by manager. + Development of medical ... content for regulatory document, and responses (including but not limited to...**You Are:** + Physician with MD or foreign equivalent; PhD nice to have + 5-10 years of clinical… more
- Chiesi (Boston, MA)
- …narratives for global stakeholders. + Partner with R&D, clinical development, regulatory , and commercial teams to ensure seamless, consistent messaging across all ... global early access and compassionate use programs, ensuring compliance with varied regulatory frameworks (eg, FDA, EMA, and other health authorities). + Leverage AI… more
- Bristol Myers Squibb (Cambridge, MA)
- …solutions. The role oversees diagnostic development from concept through regulatory approval and commercialization, manages strategic alliances, and ensures ... capabilities. Drive the development of IVD products from concept through regulatory approval, commercialization, and lifecycle management. + Establish and manage… more
- Sanofi Group (Cambridge, MA)
- …exchange and engagement. We serve as key strategic partners for commercial, regulatory , R&D, market access and external affairs to develop and launch first ... with internal experts from Global and Local Medical, Clinical Development, and Regulatory teams to develop, prioritize, and execute study design and analytical… more
- ThermoFisher Scientific (Plainville, MA)
- …and drive efficiency throughout the organization. + Support internal, external, and regulatory inspections as needed. + Hire and develop employees within the ... actions. + Serve as primary QC Bioanalytical contact for regulatory inspections and client audits. + Provide support for...BS required, MS preferred in a scientific/technical field. + PhD in a scientific/technical field is a plus. **Experience**… more